• Alizyme plc, of Cambridge, UK, received regulatory approval for a European Phase III trial of Colal-Pred in the treatment of acute ulcerative colitis. The trial, involving up to 670 patients, will aim to demonstrate the product is as effective as oral dosing with prednisolone, but without the typical side effects of steroid drugs, such as immune suppression. Colal-Pred is designed to avoid side effects by using proprietary technology to prevent the drug from being absorbed until it reaches the colon.

• Amarin Corp. plc, of London, announced positive data from a third exploratory Phase IIa trial using Miraxion as an adjunct therapy, with either SSRIs or tricyclics, to treat depression in 115 patients. The 12-week study used the Hamilton Depression Rating Scale to measure for the primary efficacy endpoint. While the entire Miraxion group did not show a significant difference vs. the placebo group, Amarin reported that the exploratory analysis demonstrated superiority in the subgroup of depression patients with melancholic characteristics using a repeated measurements design. Amarin said it is estimated that depressed patients who are unresponsive to standard treatment and have melancholic symptoms might represent about 20 percent to 30 percent of all depression patients.

• Argonaut Technologies Inc., of Redwood City, Calif., amended its definitive agreement with Biotage AB, of Uppsala, Sweden, to increase the purchase price to $21.2 million in cash and to include the sale of certain assets and the assumption of specified liabilities, including warranty service and maintenance and accounts payable of up to $350,000 associated with its remaining process development products and services. Biotage also will take on the employment responsibility for additional Argonaut employees associated with its process development business. On Feb. 21, the company entered a definitive agreement with Biotage under which Argonaut agreed to sell stock and certain assets of its consumables and flash chromatography business for about $19.9 million in cash.

• Australian Cancer Technology, of Sydney, Australia, achieved full recruitment in the company's 40-patient Phase IIb trial of its Pentrys idiotypic anti-p53 peptide vaccine in patients with hormone-refractory prostate cancer. The open-label Phase IIb study is designed to confirm the safety profile of Pentrys and to evaluate its clinical efficacy by measuring serum PSA responses.

• BioLineRx Ltd., of Jerusalem, signed a worldwide, exclusive license agreement with the European company Galmed International Ltd. for the development and commercialization of BL-1060, a small molecule for the treatment of fatty liver disease. BioLineRx said it plans to develop the project through BioLine Innovations Jerusalem and then submit it for funding by the Israeli Office of the Chief Scientist under the National Biotech Grant the company received in November. The primary indication of BL-1060, designed to modify the metabolism and storage of cholesterol and fat, is fatty liver disease, including nonalcoholic steatohepatitis associated with obesity and diabetes.

• BioXell SpA, of Milan, Italy, presented data from a Phase IIa trial of BXL628 in patients with benign prostatic hyperplasia, at the annual meeting of the European Urology Association in Istanbul, Turkey. In the 12-week, double-blind, randomized, placebo-controlled study of 119 patients, BXL628 showed a reduction of 7.2 percent in prostate volume compared to placebo (p<0.0001). Data also demonstrated that in a pre-planned analysis 29 percent of treated patients experienced a clinically significant reduction of prostate volume.

• Co.don AG, of Berlin, appointed Joerg Richter CEO, replacing Roland Alexander, a member of the company's supervisory board who had been acting CEO. The company plans to name an additional member of its board this month.

• Crucell NV, of Leiden, the Netherlands, obtained an exclusive license to certain patents of the National Institutes of Health in Bethesda, Md., to develop and commercialize recombinant vaccines against Ebola. The patents cover valuable vaccine components, such as the Ebola antigens and vectors.

• Cyclacel Group plc, of Dundee, UK, formed a research collaboration with Altana Pharma AG, a unit of Konstanz, Germany-based Altana AG, in which Cyclacel will use its expertise in mitosis or cell division to identify the molecular targets of specific Altana drugs. Altana will supply Cyclacel with molecules shown to interfere with mitosis.

• Evotec OAI AG, of Hamburg, Germany, said its soon-to-be wholly owned subsidiary Evotec Neurosciences GmbH has in-licensed a compound from an unnamed third party that has completed a Phase I trial. Because ENS aims to re-position the compound in a central nervous system indication different from the one for which it originally was developed, the company is planning a small proof-of-concept trial before deciding whether to develop the compound further. ENS is not required to make any future milestone payments or conduct any trials beyond the proof-of-concept trial.

• Gamida-Cell Ltd., of Jerusalem, appointed Yael Margolin president and CEO. Margolin has been on the board since 2000. Prior to joining Gamida-Cell, Margolin served as the vice president of Denali Ventures. Gamida-Cell is focused on the expansion of hematopoietic stem cell therapeutics in clinical development for cancer. Also, Gamida-Cell said the FDA granted orphan drug designation to the its StemEx product for use as hematopoietic support in patients with relapsed or refractory hematologic malignancies who are receiving high-dose therapy.

• Iceland Genomics Corp., of Reykjavik, Iceland, entered a cancer biomarker discovery collaboration with Basel, Switzerland-based Roche Diagnostics, to analyze patient samples to validate molecular markers for diagnostic tests to predict recurrence of cancer for selected tumor entities. The agreement provides IGC access to certain gene expression data and support for further biological characterization of the patient samples in Iceland. Financial terms were not disclosed.

• IntegraGen SA, of Paris, opened its first genetic testing facility in Bonn, Germany. Called the Expert Center, it will provide laboratory testing combined with genetic counseling. The first test to be offered will be for the diagnosis of maturity-onset diabetes of the young.

• Intercell AG, of Vienna, Austria, said Goldman Sachs International, lead manager of Intercell's initial public offering on the Vienna Stock Exchange, exercised its overallotment option that was part of the IPO. That brought the capital raised in the offering to about €52.2 million (US$68.3 million). Shares of Intercell began trading in Vienna on Feb. 28 at €5.50, and were €5.81 on March 21. Separately, Intercell partnered its Japanese encephalitis vaccine in Asia with Biological E. Ltd., of Hyderabad, India, which will manufacture the vaccine in India for the endemic Asian market. Financial terms of the deal were not disclosed.

• ITI Life Sciences, of Edinburgh, Scotland, a publicly funded inward investment company, announced a £5.3 million (US$10.1 million) program to develop tools for data mining from life sciences journals. The work will be carried out by the biological information management company Cognia Corp., of New York, which is setting up a European headquarters in Edinburgh. Cognia will collaborate with the University of Edinburgh's School of Informatics to develop natural language-processing techniques that will be commercialized by Cognia.

• Medical Discoveries Inc., of Salt Lake City, completed the acquisition of the intellectual property assets of Hamburg, Germany-based Savetherapeutics AG for €2.35 million (US$3.1 million). Savetherapeutics is developing a topical steroidal form of aromatase inhibitor for breast cancer called SaveCream. M.A.G. Capital LLC provided MDI with $3 million for the acquisition.

• MerLion Pharmaceuticals, of Singapore, and DowAgroSciences LLC, of Indianapolis, entered a collaboration to identify candidates for new agrochemical agents. The collaboration will bring together MerLion Pharma's collection of natural product samples, natural product chemistry and bioprocessing expertise with Dow AgroSciences' research and discovery engine. DowAgroSciences will apply their existing screens to candidates selected from the MerLion sample collection.

• Microscience Holdings plc, of Wokingham, UK, was awarded a £1.95 million (US$3.7 million) grant from the research charity, the Wellcome Trust, to fund Phase II trials of a single-dose oral typhoid vaccine. The trial will take place in Vietnam, where typhoid is endemic and there is widespread drug resistance. Microscience also is developing the product as a travelers' vaccine, and to date more than 100 subjects have been dosed.

• Mologen AG, of Berlin, was granted a U.S. patent (No. 6,849,725 B2) for its dSLIM technology. The patent covers a covalently closed nucleic acid molecule for immune modulation based on a DNA structure represented by specific sequence symmetries and motives.

• MorphoSys AG, of Martinsried, Germany, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, expanded their cooperation in research and therapeutic applications for five years. Boehringer has bought options on exclusive licenses for several new therapeutic antibody programs from MorphoSys. It also will have access to MorphoSys' HuCal Gold library at a number of its research sites. MorphoSys will receive a technology access fee, annual license fees and optional R&D funding, as well as milestone and royalty payments on any therapeutic antibodies that come from the collaboration. Specific terms were not disclosed.

• NascaCell IP GmbH, of Munich, Germany, and Discovery Partners International Inc., of San Diego, entered a co-marketing agreement to jointly provide aptamer-based drug discovery services to the life sciences industry. The companies are working to establish aptamers as screening tools to broaden DPI's hit- and lead-finding capabilities. NascaCell's automated in vitro selection platform allows the generation of aptamers for almost any target of choice.

• NicOx SA, of Sophia-Antipolis, France, reported results from a Phase IIa study revealing a trend in activity and promising pharmacokinetic profile for NCX 1020 in asthma patients, the company said. The results suggest NCX 1020 might have enhanced activity at counteracting bronchoconstriction and the potential for reduced systemic side effects compared to existing inhaled corticosteroids. The primary objective of the trial was to compare the ability of NCX 1020, budesonide and placebo to relax the bronchial smooth muscle of the airways following methacholine challenge. NCX 1020 showed a trend at the four-hour time point in protecting against bronchoconstriction. NCX 1020 is a nitric oxide-donating derivative of budesonide, a corticosteroid.

• Nottingham University in Nottingham, UK, is to lead a pan-European investigation of legal and ethical issues surrounding the granting of human embryonic stem cell patents by EU patent offices. The research, funded by the EU's Sixth Framework Program, will provide guidance on the legal status of stem cell patents. Current uncertainty on the issue is holding back the commercialization of human stem cells and related technologies in Europe.

• Ozgene Pty. Ltd., of Perth, Australia, said it reached a final milestone in one of its drug target validation projects for Organon NV, of Oss, the Netherlands. The milestone marks the completion of the first project in a series of studies. The contract research undertaken by Ozgene will form the basis for further studies by Organon.

• Pharming Group NV, of Leiden, the Netherlands, presented clinical results of its recombinant human C1 inhibitor (rhC1IHN) for the treatment of hereditary angioedema at its investigator meeting in Madrid, Spain. The company said patients treated with rhC1INH showed rapid time to beginning of relief - about 15 minutes - and time to complete resolution - usually within 24 hours - and showed favorable evaluation by both patients and physicians. No allergic or clinically relevant immune responses were noted. The company is conducted a placebo-controlled Phase III study in Europe and recently has expanded clinical studies to the U.S. and Canada. Preclinical studies have started to test rhC1INH in cardiovascular and inflammatory diseases, as well.

• Psiron Ltd., of North Ryde, Australia, said that its cancer therapy based on the use of a common cold virus to control cancer cell growth has begun safety testing in humans. That information was presented to the third international meeting on Replicating Oncolytic Virus Therapeutics in Banff, Alberta. The research involved the injection of a single dose of Coxsackie A21 directly into advanced melanoma tumors of patients with end-stage disease. The technology is licensed to Psiron.

• Schiffrin & Barroway LLP, of Radnor, Pa., filed a class-action lawsuit against Dublin, Ireland-based Elan Corp. plc on behalf of securities purchasers of the company's stock between Feb. 18, 2004, and Feb. 25, 2005. The complaint alleges that the company failed to disclose material adverse facts related to its multiple sclerosis drug, Tysabri, which Elan and its partner, Cambridge, Mass.-based Biogen Idec Inc., pulled off the market following a patient's death from progressive multifocal leukoencephalopathy.

• Serono SA, of Geneva, said researchers at the Serono Genetics Institute have achieved a milestone in identifying and creating a register of genes involved in multiple sclerosis. The company reported that 80 genes involved in the inflammatory and neurodegenerative pathways of the disease have been identified, based on a 40 percent genome scan that compared the genetic profile of 1,800 people with MS and healthy individuals in different populations.

• Sinovac Biotech Ltd., of Beijing, received a new drug certificate from the Chinese State Food and Drug Administration (SFDA) for its split influenza vaccine. The vaccine is the third Sinovac vaccine, along with the hepatitis A vaccine Healive and the combined hepatitis A and B vaccine Bilive, granted a new drug certificate from the SFDA. Sinovac intends to build a larger flu vaccine production facility if it can access the necessary financing.

• The Medicines Co. Inc., of Parsippany, N.J., said the European Society of Cardiology published guidelines recommending that the anticoagulant bivalirudin replace heparins in patients undergoing percutaneous coronary interventions. The recommendation was based on data from the Replace-2 trial, which showed that patients taking bivalirudin monotherapy had fewer complications and a lower mortality rate than patients treated with heparin plus GP IIb/IIIa inhibitors. Nycomed Group, of Roskilde, Denmark, and Grupo Ferrer, of Barcelona, Spain, market bivalirudin as Angiox in Europe, while the Medicines Co. markets it as Angiomax in the U.S.

• Trinity Biotech plc, of Dublin, Ireland, completed the acquisition of Research Diagnostics Inc., of Flanders, N.J., for $4.2 million in cash. RDI, which had sales last year of more than $5 million, provides monoclonal and polyclonal antibodies, antigens, proteins, enzymes and immunochemicals to research facilities, pharmaceutical companies, reference laboratories and universities worldwide.

• UK government officials announced a UK Stem Cell Initiative to formulate a 10-year vision for stem cell research. The aim is to coordinate public and private funding in collaboration with the research councils that fund public research and the proposed private sector funding body, the UK Stem Cell Foundation.